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Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Exclusivity Expiration
Akorn
TIMOLOL MALEATE
timolol maleate
Solution/Drops; Ophthalmic074465MAR 25, 1997RXNo<disabled><disabled>
Dey
ISOETHARINE HCL S/F
isoetharine hydrochloride
Solution; Inhalation089252SEP 15, 1986DISCNNo<disabled><disabled>
Pfizer
MITHRACIN
plicamycin
Injectable; Injection050109Approved prior to Jan 1, 1982RXYes<disabled><disabled>
Glaxo Wellcome
EPIVIR-HBV
lamivudine
Tablet; Oral021003DEC 08, 1998RXYes<disabled><disabled>
Steris
AMITRIPTYLINE HCL
amitriptyline hydrochloride
Injectable; Injection085594Approved prior to Jan 1, 1982DISCNNo<disabled><disabled>
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